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AstraZeneca (AZN) Enhertu Effective in HER2-Low Breast Cancer
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AstraZeneca (AZN - Free Report) and its Japan-based partner, Daiichi Sankyo’s cancer drug, Enhertu demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in phase III DESTINY-Breast04 study in patients with HER2-low metastatic breast cancer.
More than 50% of all primary breast cancers show a low-level expression of HER2, which is defined as HER2-low. This low HER2 expression level is not currently eligible for HER2-targeted therapy and is therefore a promising new target for HER2-directed antibody drug conjugate (ADC) drugs like Enhertu. The HER2-low expression occurs in both HR-positive and HR-negative disease.
In the DESTINY-Breast04 study, Enhertu demonstrated superior PFS in previously treated patients with HR-positive HER2-low metastatic breast cancer compared to the standard-of-care chemotherapy, thereby meeting the study’s primary endpoint. The study also met its key secondary endpoint of PFS in patients with HER2-low metastatic breast cancer irrespective of HR status. The study also met other key secondary endpoints of OS in patients with HR-positive disease and patients regardless of HR status at interim analysis. Enhertu’s safety profile in the study was consistent with the previous studies
The positive data from the DESTINY-Breast04 study has the potential to redefine how breast cancer is treated because no HER2-directed therapy has ever before shown any benefit in patients with HER2-low metastatic breast cancer. The DESTINY-Breast04 is the first-ever phase III study of a HER2-directed therapy to show statistically significant and clinically meaningful benefit in PFS and OS compared to standard treatment in patients with HER2-low metastatic breast cancer.
Enhertu is already approved to treat unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2-based regimens in the metastatic setting based on data from the DESTINY-Breast01 study. A supplemental biologics license application (sBLA), seeking approval for Enhertu for unresectable and/or metastatic HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regime, is under priority review with the FDA. The sBLA is based on data from the head-to-head DESTINY-Breast03 phase III study
So far this year, AstraZeneca’s shares have gained 2.7% against a decrease of 4.7% for the industry.
Image Source: Zacks Investment Research
Enhertu was approved for its second indication, HER2+, metastatic gastric cancer in January 2021. It is also being evaluated for other HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.
Enhertu is part of AstraZeneca’s flourishing oncology portfolio. Other key oncology drugs in AstraZeneca’s portfolio are Imfinzi, Tagrisso and Lynparza. AstraZeneca markets Lynparza in partnership with Merck (MRK - Free Report) .
AstraZeneca & Merck’s Lynparza is approved for four cancer types — ovarian, breast, prostate and pancreatic. Lynparza is also being evaluated in an earlier-line setting for the approved cancer indications as well some other cancer types.
Some better-ranked large stocks are GlaxoSmithKline (GSK - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , both with a Zacks Rank of 2 (Buy).
Glaxo’s stock has risen 30.1% in the past year. Estimates for Glaxo’s 2022 earnings have gone up from $3.25 to $3.30 over the past 60 days.
Glaxo’s earnings performance has been rather strong with the company beating earnings expectations in three of the last four quarters while meeting estimates in one. Glaxo has a four-quarter earnings surprise of 20.52%, on average.
Vertex Pharmaceuticals’ stock has risen 6.1% in the past year. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.32 to $14.33 per share while those for 2023 have increased from $13.85 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.
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AstraZeneca (AZN) Enhertu Effective in HER2-Low Breast Cancer
AstraZeneca (AZN - Free Report) and its Japan-based partner, Daiichi Sankyo’s cancer drug, Enhertu demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in phase III DESTINY-Breast04 study in patients with HER2-low metastatic breast cancer.
More than 50% of all primary breast cancers show a low-level expression of HER2, which is defined as HER2-low. This low HER2 expression level is not currently eligible for HER2-targeted therapy and is therefore a promising new target for HER2-directed antibody drug conjugate (ADC) drugs like Enhertu. The HER2-low expression occurs in both HR-positive and HR-negative disease.
In the DESTINY-Breast04 study, Enhertu demonstrated superior PFS in previously treated patients with HR-positive HER2-low metastatic breast cancer compared to the standard-of-care chemotherapy, thereby meeting the study’s primary endpoint. The study also met its key secondary endpoint of PFS in patients with HER2-low metastatic breast cancer irrespective of HR status. The study also met other key secondary endpoints of OS in patients with HR-positive disease and patients regardless of HR status at interim analysis. Enhertu’s safety profile in the study was consistent with the previous studies
The positive data from the DESTINY-Breast04 study has the potential to redefine how breast cancer is treated because no HER2-directed therapy has ever before shown any benefit in patients with HER2-low metastatic breast cancer. The DESTINY-Breast04 is the first-ever phase III study of a HER2-directed therapy to show statistically significant and clinically meaningful benefit in PFS and OS compared to standard treatment in patients with HER2-low metastatic breast cancer.
Enhertu is already approved to treat unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2-based regimens in the metastatic setting based on data from the DESTINY-Breast01 study. A supplemental biologics license application (sBLA), seeking approval for Enhertu for unresectable and/or metastatic HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regime, is under priority review with the FDA. The sBLA is based on data from the head-to-head DESTINY-Breast03 phase III study
So far this year, AstraZeneca’s shares have gained 2.7% against a decrease of 4.7% for the industry.
Image Source: Zacks Investment Research
Enhertu was approved for its second indication, HER2+, metastatic gastric cancer in January 2021. It is also being evaluated for other HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.
Enhertu is part of AstraZeneca’s flourishing oncology portfolio. Other key oncology drugs in AstraZeneca’s portfolio are Imfinzi, Tagrisso and Lynparza. AstraZeneca markets Lynparza in partnership with Merck (MRK - Free Report) .
AstraZeneca & Merck’s Lynparza is approved for four cancer types — ovarian, breast, prostate and pancreatic. Lynparza is also being evaluated in an earlier-line setting for the approved cancer indications as well some other cancer types.
Zacks Rank and Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked large stocks are GlaxoSmithKline (GSK - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , both with a Zacks Rank of 2 (Buy).
Glaxo’s stock has risen 30.1% in the past year. Estimates for Glaxo’s 2022 earnings have gone up from $3.25 to $3.30 over the past 60 days.
Glaxo’s earnings performance has been rather strong with the company beating earnings expectations in three of the last four quarters while meeting estimates in one. Glaxo has a four-quarter earnings surprise of 20.52%, on average.
Vertex Pharmaceuticals’ stock has risen 6.1% in the past year. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.32 to $14.33 per share while those for 2023 have increased from $13.85 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.